RecruitingNot ApplicableNCT07532811

Evaluation of Perfusion and Ventilation Distribution in Children: a Pilot Study.

Feasibility Study of the Evaluation of Perfusion and Ventilation Distribution in Children : a Pilot Study

Sponsor

Hospices Civils de Lyon

Enrollment

20 participants

Start Date

May 13, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Respiratory Failure

Summary

Electrical impedance tomography (EIT) is a recent monitoring technique that provides information on regional ventilation distribution. Following the injection of a hypertonic saline bolus, EIT can also assess regional pulmonary perfusion distribution, allowing evaluation of the ventilation/perfusion (V/Q) ratio. In adults, protocols for assessing perfusion distribution require the injection of 10 mL of a 7.5% or 10% NaCl solution or sodium bicarbonate over a few seconds. Studies have reported good hemodynamic tolerance, adequate image quality, and no significant changes in serum sodium levels. However, this volume and sodium load are not appropriate for small children. To date, no pediatric protocol exists for assessing pulmonary perfusion distribution and the ventilation/perfusion ratio using EIT. It is therefore proposed to conduct a pilot study to evaluate the feasibility of assessing pulmonary perfusion by EIT using a weight-adjusted bolus of hypertonic saline (NaCl or sodium bicarbonate).

Eligibility

Max Age: 12 Years

Inclusion Criteria5

patients < 12 years hospitalized in pediatric intensive care
intubated, under conventional invasive mechanical ventilation and sedated
between 3 and 40 kg
with central venous access in the superior vena cava
consent signed by parents or legal guardians

Exclusion Criteria11

Patients with significant leaks > 20% around the endotracheal tube
Patients receiving spontaneous ventilation (inspiratory support, NIV, etc.)
Natremia > 150 mmol/L at inclusion
Hyperchloremia ≥ 115 mmol/L and/or hypokaliema ≤ 3 mmol/L
Patients with intracranial hypertension
Patients with active bleeding or persistent hemodynamic instability despite amines
Patients with heart failure, uncorrected cyanotic heart disease, or a history of cardiac arrhythmia
Patients with contraindications to the use of the electrical impedance pulmonary tomography belt (skin lesions, burns, or recent thoracic surgery)
Conditions in which EIT data acquisition will be disrupted (chest dressings, pneumothorax, ECMO)
Patients with severe hypoxemia defined as FiO2 > 90% to maintain SpO2 > 88%
Individuals not affiliated with a social security system or beneficiaries of a similar system

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Interventions

OTHEREvaluation of perfusion with Electrical impedance tomography using sodium chloride or sodium bicarbonate

All patients will undergo EIT monitoring (Enlight 2100, Timpel, Brazil) using a belt adjusted to the thoracic circumference. Ventilation distribution will be assessed with a tidal volume of 8 mL/kg. Following a breath hold, a saline solution (sodium chloride or sodium bicarbonate) will be injected over a few seconds. Perfusion distribution, as well as impedance signal variation, will be recorded using dedicated software (Timpel, Brazil). Data acquisition will be considered valid if the impedance signal variation induced by the saline solution injection is at least equivalent to the amplitude variation observed during ventilation with a tidal volume of 8 mL/kg. 2 measurements at 4 to 6-hours intervals with volume or concentration adjustment after the first injection if needed in the group 1